1. Field of the Invention
This invention is in the field of compositions of matter such as drug units, applied in the form of doses thereof to treat or cure a disease, such as cancer. Drug units are formed of cancer cell killing biological elements, such as white blood cells, which are targeted to specific cancer cells by antibodies or antibody fragments bonded to such white blood cells, coating material thereon or a microcapsule or vesicle in which one or more of such cells are encapsulated.
2. The Prior Art
It is known to produce antibodies by genetic engineering, referred to as monoclonal antibodies, which are surface configured and constructed to permit them to target to or be retained against specific antigens in a living being, such as specific types of cancer cells. Marker-specific antibodies have been produced by a number of techniques such as disclosed in the text "Immunodiagnosis of Cancer", Herberman et al, Eds. (Marcel Dekker, Inc., New York and Basel, 1979) and in the text "Cancer Markers", Sell, Ed. (Humana Press, Clifton, N.J. 1980). U.S. Pat. Nos. 3,927,193; 4,036,945; 4,331,647; 4,444,744; 4,460,959; 4,460,561; 4,172,124 and others describe methods for producing monoclonal antibodies and antibody fragments which are specific to cancer cells or tumor associated markers to permit them to be used for cancer detection, localization and therapy. Other U.S. patents which teach the production of monoclonal antibodies include: U.S. Pat. Nos. 4,434,230; 4,423,034; 4,381,925; 4,364,397 and 4,364,396.
It is also known in the art to secure or bind such monoclonal antibodies or incorporate therein radioactive materials and particles of radioactive or inactive nuclides for the purposes of detecting and treating cancer when the antibodies target to specific cancer cells, such as existing on the surface of tumors. U.S. Pat. Nos. 4,331,647; 4,444,744; 4,460,559; 4,460,561; & 4,348,376 & 4,311,688 to Goldenberg disclose such tumor localization and therapy using labeled antibody fragments and include methods for producing such labeled fragments or drug units.
A method for entrapping therapeutic agents within cells is disclosed in U.S. Pat. No. 4,446,951 to Pittman.
Various methods are also known as liposomes and the like. Unilamellar vesicules are described in U.S. Pat. No. 4,310,506 while various types of lipsomes including certain which are polymer stabilized and their production are described in U.S. Pat. Nos. 4,448,765; 4,310,505; 4,310,506 and 4,429,008 and the references therefore. Cancer drug delivery techniques and compositions are disclosed in U.S. Pat. Nos. 4,460,560 and 4,466,951 and the references therefore.
The treatment of cancer in living beings has involved a variety of techniques, each of which suffers shortcomings and serious side effects. Therapy employing radioactive materials, such as radioisotopes injected into the tissue or bloodstream of a living being or radiation directed through the body to a cancer site, detrementally affects or destroys normal as well as diseased tissue or cancer cells. Chemical agents injected into the body also results in destroying or detrimentally affecting healthy tissue.
Recently, doses of lymphocytes produced from a patient's own blood and activated with an immune system activator, such as interlukin-2, a natural substance derived from the body and producable by genetic engineering, have been administered to persons with cancer by injection and allowed to circulate in the blood with positive results in the form of tumor remission. However, such technique suffers shortcomings associated with any drug which is administered in large doses to circulate freely in the bloodstream until a portion thereof encounters a tumor which may be localized at one site in the body remote from the point of injection of the drug. Side effects may also include attack by such killer lymphocyte cells on healthy tissue cells and/or other beneficial factors in the body. Such technique also involves the use of relatively large doses of such activated lymphocytes as only a portion of those administered reach and react on the disease or cancer site.